Status:
NOT_YET_RECRUITING
Trial of ctDNA of Guidance to Determine PostOperative Radiation Therapy
Lead Sponsor:
Rutgers, The State University of New Jersey
Conditions:
Lung Cancer
Non Small Cell Lung Cancer
Eligibility:
All Genders
18-90 years
Phase:
EARLY_PHASE1
Brief Summary
Primary Objective: Evaluate the role of ctDNA positivity in decision making for postoperative therapy for non-small cell lung cancer. The plan for postoperative therapy will be declared after patholo...
Detailed Description
This is a pilot, single-arm interventional study evaluating the use of the Haystack™ circulating tumor DNA (ctDNA) assay to guide postoperative radiation therapy (PORT) and systemic therapy decisions ...
Eligibility Criteria
Inclusion
- Have provided signed informed consent for the trial
- Aged ≥18 years at the time of informed consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Diagnosed with histologically confirmed Stage II-III NSCLC and undergone surgical resection of lung tumor
- No active second cancers/malignancy
- Patients that received preoperative therapy (including chemotherapy and immunotherapy or others) are eligible
- Willing and able to comply with all aspects of the protocol
- Standard of care therapy and methods as per institution and investigator discretion -
Exclusion
- Exclusion Criteria
- Discontinued treatment due to a Grade 3 or higher AEs with chemotherapy or immunotherapy or targeted therapy agent
- With a history of another primary malignancy within the past 2 years that is considered an active malignancy by the enrolling physician.
- Have known active CNS metastases and/or carcinomatous meningitis.
- Have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis.
- Have a history of interstitial lung disease.
- Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. -
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06979661
Start Date
June 1 2025
End Date
June 1 2029
Last Update
May 20 2025
Active Locations (1)
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1
Rutgers Cancer Institute
New Brunswick, New Jersey, United States, 08901